Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Launched by LAPLACE INTERVENTIONAL, INC · Dec 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new procedure called the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System. It aims to determine how safe and effective this system is for patients with a heart condition known as tricuspid regurgitation, where the heart's tricuspid valve doesn’t close properly, leading to blood flowing backward. The trial is currently recruiting participants who are between 22 and 90 years old and have symptoms of this condition despite receiving the best medical treatment for at least 30 days. Eligible participants must also have severe tricuspid regurgitation confirmed by heart imaging tests.

If you or a loved one qualifies for this study, you can expect to undergo a procedure using this new device, with careful monitoring by a team of heart specialists. Participants will need to commit to follow-up visits after the procedure to assess their progress and health. It’s important to note that certain health conditions may prevent someone from participating, such as severe heart dysfunction or recent major heart events. This trial is a chance to help improve treatment options for people with this heart condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 22 - 90 years of age at the time of the study procedure
• • 2. Symptomatic tricuspid regurgitation despite being adequately treated with optimal medical therapy by the Local Heart Team for at least 30 days prior to the time of study consent.
• • 3. Severe, massive or torrential tricuspid regurgitation determined by qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE) using the 5-grade classification.
• • 4. Candidate felt suitable for transcatheter tricuspid valve replacement as determined by the local heart team and confirmed by the patient selection committee. For patients with pre-existing trans-tricuspid pacemaker or ICD leads, the local heart team shall include an electrophysiologist.
• • 5. Subject or legally authorized representative has provided informed consent and agrees to return for all required post-procedure follow-up visits
• Exclusion Criteria:
• • 1. Estimated life expectancy of less than 12 months
• • 2. PVR \>5 Wood units
• • 3. Echocardiographic evidence of severe right ventricular dysfunction
• • 4. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment
• • 5. Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
• • 6. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery, within last 30 days. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator or leadless pacemaker within 90 days prior to the study procedure
• • 7. Stroke or other major cerebrovascular event within 90-days prior to index procedure
• • 8. Untreated clinically significant coronary artery disease requiring revascularization, recent (within last 30 days) acute coronary syndrome or myocardial infarction.
• • 9. Bleeding disorders including thrombocytopenia or platelet count \<70,000 mm3 or thrombocytosis (platelet count \>700,000 /mm3)
• • 10. Current or planned pregnancy within next 12 months for women of childbearing potential
• • 11. Active or recent endocarditis within last 90 days or, sepsis/ other systemic infection requiring oral or intravenous antibiotics within last 30 days
• • 12. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements. Any patient considered to be vulnerable.
• • 13. Left ventricular ejection fraction (LVEF) \< 30%